To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

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This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen

Condition or disease

Intervention/treatment

Phase

Prostate Cancer

Biological: sipuleucel-T

Phase 2

Detailed Description:

This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects.

Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10^7 peripheral blood mononuclear cells (PBMCs) per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.

Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. [ Time Frame: Baseline, Months 2, 4 and 6. ]

An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.

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Ages Eligible for Study:

18 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.

A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.

A requirement for systemic immunosuppressive therapy for any reason.

A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or granulocyte-macrophage colony-stimulating factor.

Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.